We supply Saw Palmetto Extract in 25% and 45% total fatty acid grades – a widely used botanical ingredient for men’s health, urinary tract support, and hormone balance formulations.

Basic Information

Product Description

Saw Palmetto Extract is obtained from the dried fruit of Serenoa repens (W.Bartram) Small. It is a small palm tree native to the southeastern United States, particularly Florida and the Gulf Coast region.

Two total fatty acid grades are available – 25% and 45%. The 25% grade offers a balanced option for multi-ingredient urinary tract formulations. The 45% grade is the most commonly specified concentration in clinical research and premium prostate support products.

The active fraction consists mainly of medium- and long-chain fatty acids together with phytosterols. The primary fatty acids are palmitic acid and stearic acid. The principal phytosterol is beta-sitosterol. These lipid-soluble constituents are standardised by GC-FID and GC-MS methods.

Active Constituents

The bioactive profile of Saw Palmetto Extract is dominated by lipid-soluble compounds – fatty acids and phytosterols. Our standardisation covers total fatty acids and total phytosterols as primary markers. Beta-sitosterol serves as a secondary quality indicator.

Primary Markers: Total Fatty Acids and Total Phytosterols

Total fatty acid content is determined by GC-FID. The main fatty acid constituents are palmitic acid (C16:0) and stearic acid (C18:0), which together account for the majority of the fatty acid fraction.

Total phytosterol content is quantified by GC-MS. The three principal phytosterols in saw palmetto fruit extract are beta-sitosterol, campesterol, and stigmasterol. We report total phytosterols as a percentage on every COA.

Secondary Marker: Beta-Sitosterol

Beta-sitosterol (CAS 83-46-5, C29H50O, MW 414.72) is quantified by HPLC-DAD. It is the most abundant phytosterol in saw palmetto fruit extract and is recognised as the principal marker compound in the EMA herbal monograph.

COA Standard Specifications

Mechanism of Action

5-Alpha-Reductase Inhibition

The fatty acid and phytosterol fraction of saw palmetto extract inhibits the enzyme 5-alpha-reductase. This enzyme converts testosterone to dihydrotestosterone (DHT). Lower DHT levels may reduce prostatic cell proliferation.

Anti-Inflammatory Activity

Beta-sitosterol and other phytosterols in the extract exhibit anti-inflammatory properties. They modulate cyclooxygenase and lipoxygenase pathways. This action may support urinary tract comfort and function.

Anti-Androgenic Effects

Saw palmetto extract has demonstrated mild anti-androgenic activity in vitro. The liposterolic fraction competes with DHT binding to androgen receptors in prostatic tissue. This mechanism supports its traditional use for prostate health.

Hair Follicle Support

Topical applications of saw palmetto extract are investigated for hair care. The 5-alpha-reductase inhibitory activity may reduce DHT-mediated hair follicle miniaturisation. This supports its use in cosmetic hair care formulations.

Traditional and Modern Use

Saw Palmetto has a long history of use in Native American medicine. Indigenous peoples of the southeastern United States used the fruit to support urinary health and relieve bladder discomfort.

In contemporary practice, Saw Palmetto Extract is incorporated into dietary supplements targeting prostate health and urinary tract support. It is also used in cosmetic hair care products due to its potential 5-alpha-reductase inhibitory activity.

The EMA has published a monograph on Serenoa repens fruit for traditional use in mild urinary complaints associated with benign prostatic hyperplasia. The recommended traditional dose is 160 mg twice daily or 320 mg once daily of a liposterolic extract.

Regulatory Status

Saw Palmetto is regulated differently across major markets.

In the United States, Serenoa repens is not listed in the FDA EAFUS database. It is widely available as a dietary supplement under DSHEA. The FDA has issued warning letters to companies making unapproved drug claims for saw palmetto products. Saw palmetto is not approved as a prescription drug by the FDA.

In the European Union, Serenoa repens fruit is covered by an EMA herbal monograph. It is authorised for traditional use in some EU member states for mild urinary complaints associated with benign prostatic hyperplasia. It is not classified as a Novel Food under Regulation (EU) 2015/2283.

In China, Serenoa repens is not listed in the Chinese Pharmacopoeia. There are no known cultivated or wild resources of Serenoa repens in China. The raw material is imported from the United States. It is sold as a dietary supplement ingredient subject to China’s food safety regulations.

Important clinical note: Two large, high-quality trials (Garcia 2006, NEJM; Jacobsen 2012, JAMA) found saw palmetto no better than placebo for BPH symptoms. Manufacturers should ensure all marketing complies with local regulations and does not make unsupported therapeutic claims.

Recommended Usage

Typical daily intake is 320 mg of total fatty acid-standardised extract. This is the most commonly studied dose in clinical research.

Formulation guidance by grade:

25% grade: Suitable for multi-ingredient blends at 640-1,280 mg per day

45% grade: Optimal for single-ingredient prostate support at 320-640 mg per day

Clinical studies have used a liposterolic extract standardised to 85-95% fatty acids and sterols at 320 mg per day (divided into two 160 mg doses). The 45% grade is closer to this clinical standard than the 25% grade.

Precautions

IMPORTANT SAFETY NOTE: Saw Palmetto is not a substitute for medical treatment of benign prostatic hyperplasia or other urinary conditions. Clinical evidence from large randomised trials does not support its efficacy for BPH. Always advise clients to comply with local advertising and supplement regulations.

General Precautions

Do not exceed the recommended daily dosage. Pregnant and breastfeeding women should avoid Saw Palmetto Extract due to potential hormonal effects. Discontinue use at least two weeks before any scheduled surgery.

Drug Interactions

Consult a healthcare professional before use if taking anticoagulant or antiplatelet medications. Saw Palmetto may increase the risk of bleeding. It may also interact with hormone-sensitive medications, including oral contraceptives and hormone replacement therapy.

Contraindications

Not recommended for children, pregnant or breastfeeding women, or individuals with known hypersensitivity to Arecaceae family plants. Individuals with bleeding disorders should avoid use without medical supervision.

When to Discontinue

Discontinue use and consult a healthcare provider if you experience gastrointestinal discomfort, headache, dizziness, or any allergic reaction. Stop use if symptoms persist or worsen. This product is not intended to diagnose, treat, cure, or prevent any disease.

Disclaimer

This product is not intended to diagnose, treat, cure, or prevent any disease. Statements regarding this product have not been evaluated by the Food and Drug Administration.

Saw Palmetto is not approved as a drug by the FDA or any other regulatory authority. It is marketed as a dietary supplement ingredient or cosmetic ingredient where applicable. Large clinical trials have shown saw palmetto to be no more effective than placebo for BPH symptoms. Consumers should consult a healthcare professional before use, particularly if taking medication or managing a chronic health condition.

Keep out of reach of children. Store below 25°C in a dry place.

Why Choose Nutraligting

Precisely Match Your Formulation Standards

We never supply untested ordinary bulk saw palmetto powder. Every batch of extracts with 25% and 45% total fatty acid specifications is fully tested via GC-FID gas chromatography. A dedicated batch-specific COA quality inspection report with clearly marked accurate fatty acid content is provided along with each shipment.

Custom Extraction Solutions for Your Unique Product Needs

Our in-house botanical R&D team is not limited to the regular 25% and 45% specifications. We can adjust the extraction process, optimize dissolution properties, and develop customized indicators that fully match your formulation requirements.

References

Garcia, R.D., et al. (2006). “Saw Palmetto for Benign Prostatic Hyperplasia.” New England Journal of Medicine, 354(6), 557-566. PMID: 16467545.

Jacobsen, D.J., et al. (2012). “Effect of Saw Palmetto on Urinary Symptoms and Prostate Growth in Men with Benign Prostatic Hyperplasia: A Randomized Clinical Trial.” JAMA, 307(7), 685-692. PMC3442774.

Wilt, T.J., et al. (2000). “Saw Palmetto Extract for Treating Urinary Symptoms in Benign Prostatic Hyperplasia: A Systematic Review of Randomized Controlled Trials.” BMC Urology, 1, 2. PMC3798925.

National Institute of Standards and Technology (NIST). “SRM 3251: Serenoa repens Extract.” Standard Reference Material Certificate. Gaithersburg, MD.

European Medicines Agency (EMA). “Community Herbal Monograph on Serenoa repens (W.Bartram) Small, fructus.” EMA/HMPC/280079/2013.

Alibaba supplier listings. “Serenoa Repens Saw Palmetto Fruit Extract 25% 45% Total Fatty Acids” – commercial COA data, verified palmitic acid CAS 57-10-3, stearic acid CAS 57-11-4, beta-sitosterol CAS 83-46-5.